Medi­gene, RXi strike re­search deal to im­prove TCRs; Bris­tol-My­ers pays PsiOxus $15M mile­stone for tri­al-ready on­colyt­ic virus

→ A pre­clin­i­cal re­search col­lab­o­ra­tion has brought Marl­bor­ough, MA-based RXi Phar­ma­ceu­ti­cals and Ger­many’s Medi­gene to­geth­er in hopes of im­prov­ing Medi­gene’s adaop­tive T-cell can­cer ther­a­pies. The plan is to in­te­grate tiny RXi’s self-de­liv­er­ing RNAi tech­nol­o­gy in­to Medi­gene’s process to pro­duce re­cep­tor-mod­i­fied T cells, which can in turn be di­rect­ed against a pre­de­fined tu­mor anti­gen. “The use of our im­muno-on­col­o­gy sd-rxR­NA com­pounds with their re­cep­tor-mod­i­fied T cells could po­ten­tial­ly cre­ate a next gen­er­a­tion of very pow­er­ful adop­tive cell ther­a­pies against se­ri­ous can­cers that cur­rent­ly are dif­fi­cult to tar­get,” said RXi CEO Geert Cauwen­bergh in a state­ment.

→ Eu­ro­pean biotech ar­genx is launch­ing a $150 mil­lion of­fer­ing of its shares in the US. The com­pa­ny will use the cash to fur­ther de­vel­op its pipeline in au­toim­mune dis­eases and can­cer. Ar­genx has an au­toim­mune pro­gram called ARGX-113, which is cur­rent­ly in three Phase II clin­i­cal tri­als. The drug is be­ing test­ed in myas­the­nia gravis, im­mune throm­bo­cy­tope­nia, and pem­phi­gus vul­garis. The com­pa­ny’s Amer­i­can De­posi­tary Shares are cur­rent­ly list­ed on the Nas­daq Glob­al Se­lect Mar­ket un­der stock stym­bol $ARGX, while its or­di­nary shares are on Eu­ronext Brus­sels.

→ Ox­ford biotech PsiOxus Ther­a­peu­tics has earned a $15 mil­lion mile­stone pay­ment from part­ner Bris­tol-My­ers Squibb (BMS) $BMY for scor­ing ap­proval of their Clin­i­cal Tri­al Ap­pli­ca­tion for NG-348, an “armed” on­colyt­ic virus for the treat­ment of sol­id tu­mors. The deal be­tween the two com­pa­nies was first writ­ten up in De­cem­ber 2016, when BMS paid PsiOxus a $50 mil­lion up­front pay­ment in a li­cens­ing agree­ment worth up to $936 mil­lion (plus roy­al­ties). Af­ter pre­clin­i­cal de­vel­op­ment of NG-348, BMS is tak­ing over glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion. PsiOxus says its on­coloyt­ic virus ther­a­py us­es a mod­i­fied ade­n­ovirus that repli­cates with­in tu­mor cells and not with­in nor­mal tis­sue, stim­u­lat­ing an im­mune re­sponse in the tu­mor mi­croen­vi­ron­ment.

Por­to­la $PT­LA an­nounced to­day that the EMA’s Com­mit­tee for Med­ical Prod­ucts for Hu­man Use has re­quest­ed ad­di­tion­al in­for­ma­tion re­gard­ing the Mar­ket­ing Au­tho­riza­tion Ap­pli­ca­tion for be­trix­a­ban. The drug, which was ap­proved in the US in June as Bevyxxa with mixed as­sess­ment, pre­vents ve­nous throm­boem­bolism (aka blood clot­ting) in high-risk, acute­ly ill pa­tients. The com­pa­ny did not spec­i­fy what the CHMP wants, but said they be­lieve ex­ist­ing clin­i­cal da­ta will be able to ad­dress the ques­tions, and ex­pect an opin­ion lat­er in the first quar­ter of 2018.

With ad­di­tion­al re­port­ing by Brit­tany Meil­ing.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Top an­a­lyst of­fers a rare, up­beat in­ter­pre­ta­tion of Ab­b­Vie’s $63B Al­ler­gan deal — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took at 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

→ In a mar­riage of two tech­nolo­gies meant to make cell ther­a­pies more pow­er­ful, SQZ Biotech is team­ing up with France’s Ery­tech Phar­ma for a col­lab­o­ra­tion, with $57 mil­lion re­served for the first project and $50 mil­lion for each sub­se­quent ap­proval (prod­uct or in­di­ca­tion). Hav­ing ac­cess to Ery­tech’s method of fash­ion­ing ther­a­peu­tics from red blood cells, the Cam­bridge, MA-based com­pa­ny said, will am­pli­fy SQZ’s cell en­gi­neer­ing ca­pa­bil­i­ties and al­low them to de­vleop a new class of im­munomod­u­la­to­ry ther­a­pies. Its own tech — so far ap­plied in can­cer but al­so has po­ten­tial in di­a­betes — tem­po­rary dis­rupts the cell mem­brane by squeez­ing the cell, thus cre­at­ing a brief win­dow for tar­get ma­te­ri­als such as anti­gens to en­ter.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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